Self-Hypnosis for Intrapartum Pain management (SHIP) trial

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN27575146
• Date of registration: 25/03/2011
• Prospective Registration: No
• Primary sponsor: East Lancashire Hospitals NHS Trust (UK)
• Public title: Self-Hypnosis for Intrapartum Pain management (SHIP) trial
• Scientific title: Self-Hypnosis for Intrapartum Pain management (SHIP): a single organisation, two-site pragmatic exploratory non-blinded randomised controlled trial with blinded analysis based on intention to treat, and contextualised by interviews, focus groups, logs, and questionnaires
• Date of first enrolment: 01/12/2010
• Target sample size: 600
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN27575146
• Study type: Interventional
• Study design: Multicentre pragmatic exploratory non-blinded randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Soo Downe

Key inclusion & exclusion criteria

Inclusion criteria: All nulliparous women who:
1. Have a singleton, viable, cephalic pregnancy
2. Are planning a vaginal birth in hospital
3. Have no current history of being under treatment for psychiatric disorders or of hypertensive disorders
4. Speak and read English
5. Consent to take part
6. Who are available to attend the intervention sessions
7. Aged between 18 and 45 years
Exclusion criteria: Does not meet the inclusion criteria

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Intrapartum maternity care
Pregnancy and Childbirth
Pain management

Intervention(s)

Intervention group:
1. Each group hypnosis programme will be provided by one of 4 midwives with appropriate training
2. They will not be present during the labour and birth of study participants
3. The programmes will be provided in addition to usual care
4. Each programme will be delivered on one of the two Trust sites, with evening or weekend options, to groups of 5 - 10 women and their planned birth companions (a total maximum of 20 people) in 2 sessions separated by 3 weeks (32 weeks gestation, 35 weeks gestation
5. Each session will last 90 minutes
6. Four sets of hypnosis programmes will be run every 4 weeks with evening and weekend options
7. The hypnosis scripts will be adapted from those tested in the current Australian Hatch Trial
8. The sessions will include self-hypnosis induction techniques, exercises relating to confidence, coping and strength in labour, suggestions for time distortion, a labour rehearsal involving recurrent fractionation and staircase imagery, and pain control and dissociation techniques. Participants will also be asked to listen to a CD of reinforcement exercises at least once a day until their baby is born

Control group:
'Usual care' will consist of attendance at any antenatal classes usually offered to nulliparous women, and standard clinical care

Women in both groups will be free to request any additional pain relief they require during labour, and this will be emphasised in the information leaflets.

Primary Outcome(s)

Rates of epidural usage in labour for maternal request

Secondary Outcome(s)

1. Mode of birth and other maternal labour outcomes
2. Neonatal wellbeing
3. Participants preferences relating to hypnosis
4. Anxiety and fear about labour
5. Recall of labour pain
6. Ability to manage labour
7. Satisfaction with self during labour
8. Clinical and psychological morbidity and well-being
9. Economic cost-benefit analysis
10. Experiences of women, their birth companions, and their caregivers
11. Follow up will continue to 6 weeks postnatal

Secondary ID(s)

PB-PG-0808-16234

Source(s) of Monetary Support

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-16234)